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Are Academic Medical Center Clinical Trials Going the Way of Oldsmobile?

Are Academic Medical Center Clinical Trials Going the Way of Oldsmobile?. Cincinnati Innovations in Healthcare Delivery 2006 David Dilts PhD, MBA Professor & Director, Management of Technology Program, School of Engineering

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Are Academic Medical Center Clinical Trials Going the Way of Oldsmobile?

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  1. Are Academic Medical Center Clinical Trials Going the Way of Oldsmobile? Cincinnati Innovations in Healthcare Delivery 2006 David Dilts PhD, MBA Professor & Director, Management of Technology Program, School of Engineering Professor & Director, Center for Management Research in Healthcare (www.cmrhc.org) Owen Graduate School of Management Vanderbilt University David.dilts@vanderbilt.edu

  2. The will is infinite and the execution confined, The desire is boundless and the act a slave to limit. Shakespeare, Troilus and Cressida

  3. Research Focus • Transfer hard won lessons-learned from one domain to another Note: Every setting is “special” in some ways, but typical in others

  4. 1970 Corvette Stingray 1970 Toyota Carina Remember When (1970’s) The president warned that Americans were wasting too much energy, that domestic supplies of oil and natural gas were running out– Jimmy Carter

  5. What’s Happened Since

  6. Two Days in July & August • July 3, 2006: North America Sales • GM Sales ▼26% (37% in light trucks) • Ford Sales ▼6.9% • DaimlerChrysler ▼15% • Toyota Motor ▲14% (22% in passenger cars) • Nissan ▼19% • August 1, 2006 • Toyota became the 2nd biggest selling auto company in the United States • Toyota sales▲16.2%, Ford sales ▼32% • Honda outsold the Chrysler Group • Honda sales▲10.5%, Chrysler sales ▼31.5%

  7. Not convinced yet? • August 18, 2006: • Ford to cut 21% of its N.A. production, will partially shut down at least 10 plants • Ford & GM credit-ratings are five notches below investment grade (just above junk bond status) • Sept 6, 2006 • Bill Ford, jr, resigns as Ford CEO

  8. A telling statement • “We are trying to figure out how and how much you advertise new products that are going into (a) segment that may be DOA” • A Ford SUV manager • WSJ, Aug 19-20, 2006, p. A7

  9. ▲155% ▼42% Development Time in General

  10. Question: • Why does it take ~60 months to develop & certify a new jet aircraft but it takes: • 38% (~23 months) longer for New Drug Development & Approval Times • (Tufts CSDD Report 2003, Vol. 5, No. 2) • 48% (~29 months) longer for New Biopharmaceutical Development & Approval Times • (Tufts Center for the Study of Drug Development Outlook 2004)

  11. What US Manufacturing Discovered: • U.S.A. was • best in the world, once we started manufacturing • worst in the world, at getting ready to manufacture, i.e., set-up times • When Henry Ford Designed the River Rouge Factory in 1927 for the Model A: • 95% Direct Labor costs, 5% other costs • From “ore to assembly” • “…easily the greatest industrial domain in the world” DL Lewis • By 1985 • <50% of workers were in direct labor • “World-class” = “Made in Japan”

  12. (Morison, EE 1966 Men, Machines, and Modern Times, MIT Press.) Focusing on Setups:The Process Thought-To-Be versus As-Is • Do not assume that the set-up time is fixed • Specifically study what is done (not what is thought to be done) and why each action is done

  13. Target Identification and Validation ↓ Assay Development ↓ Lead Generation Lead Optimization $500-600 MM Pre-Clinical Develop-ment PhaseI Phase II Phase III Global Launch Global Optimization Registra- tion Time 8 – 12 Years The Risk/Cost/ Time Development Paradigm Focusing on the “Elbow” Hypothesis Generation Clinical Candidate Development Commercialization $800 MM Cumulative Investment $200-300 MM $20-60 MM Risk Barker, Anna, TRWG, 2/2006

  14. What Must Be Done Before Any Clinical Trial • Infrastructure Processes, • i.e., The Dreaded TLAs • IRBs: Institutional Review Boards • SRCs: Scientific Review Committees • C&Gs: Contracting & Grants Office • CTOs: Clinical Trial Offices • CRCs: Clinical Research Centers

  15. Current Study Settings • Community Groups • Vanderbilt-Ingram Cancer Center Affiliates Network (VICCAN) home office • 3 VICCAN member sites • Memorial, Chattanooga, TN • Central Georgia Hem/Onc (CGHO), Macon, GA • Meharry Medical College (MMC), Nashville, TN • Comprehensive Cancer Center (VICC) • Academic Medical Center (VUMC) • Cooperative Oncology Group • Cancer and Leukemia Group B (CALGB)

  16. Method • Part I: Process Mapping • Extensive visits at each site to document processes, loops and decisions: • Say: What they say they do • Should: What policies and procedures say they should do • Do: What study chart reviews show they actually do • Creation of process map • Part II: Process Timing • Identify calendar time for total process and major steps, and potential influencers of the time • Part III: Bottleneck Timing • Using the identified bottleneck process, drill down to discover why • Part IV: Fix the processes • Key Aspects: • What are the bottleneck or constraining processes? • What is the critical path to opening a study? Dilts and Sandler (2006) “The Invisible Barriers to Opening Clinical Trials, J Clin Onc, 24(28), xxx

  17. Investigator-Initiated Clinical Trials At VICC – Level 0 Diagram Clinical Trial Steps Set-up Steps

  18. Process Map at CALGB • Steps to activate a study • Opening a study requires the additional steps shown previously • And both come before the 1st patient on study 30 ft x 5 ft in 8 pt font

  19. To open or activate a study… Note: Some signatures take less than a minute to obtain… … others take up to 60 days Dilts et al. (2006) “Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group, the case of CALGB”, J Clinical Oncology, 24(28), xxx.

  20. 26 Paperwork 29 Approvals 8 Primary Participants 3 Secondary Participants 9 Stopping Points 1 Study Approved 12 Value-Added Activities More In-Depth Look at VICC IRB

  21. Some Statistics

  22. Part II Timelines Key Issue: What is the bottleneck or constraining process?

  23. Major Processing Activities Median= 784 days

  24. Note: In the studies investigated, expedited studies were only opened 15 days faster than nonexpeditied studies Results of Expediting

  25. Timing At VICC:studies received between 1/1/01 to 12/31/05:

  26. Part III: Drilling Down on Contracts & Grants at VUMC Dependent Variable: Time from Receipt to Signature (days)

  27. One Other Disturbing Statistic: If insufficient patients are accrued, then all process steps are non-value added!

  28. CALGB Phase III Accruals for Trials Investigated Phase III Accrual Rates at CALGB 15% of all studies activated in a 5 year period resulted in no accruals

  29. Phase III- More and Deeper • 2nd Major NCI Grant • Study Settings: • Eastern Cooperative Oncology Group (ECOG) • 4 Comprehensive Cancer Centers • Cancer Therapy Evaluation Program (CTEP) • Studying CTEP is equivalent to being allowed to study how the IRS makes its decisions. • Outcomes • Individual process maps for each group • Timing data study for all sites • Projected Phase IV • Major roundtable to dramatically improve the system • Other activities: • EDRN – early detection research network • CTWG –clinical trials working group • TRWG – translational research working group • & pharmaceutical firms are becoming interested

  30. What Drug Companies are Doing • “29% of our clinical trials are now done abroad, we expect that figure to jump to 50% in two years.” • Tadataka Yamada, GlaxoSmithKline’s Chairman of R&D • Discussing a post-marketing clinical trial for two cardiovascular drugs – involving 46,000 patients in 1,250 hospitals in China – cost $3 million. “Could you do it in Europe? I don’t think so.” • Tom McKillop, Former CEO of AstraZeneca (quoted in WSJ, 2/14/2006) • “For a Phase II trial, the cost for 100 patients in China could be as low as $25,000, while in the U.S. or Europe, it could range from $500,000 to $1 million • Dr. Ikeguchi, Medidata Solutions (quoted in WSJ 2/14/2006)

  31. Don’t look to the government to bail out AMCs • “NIH Budget Falls for the First Time in 36 Years” AAAS R&D Funding update • http://www.aaas.org/spp/rd/nih06f.htm • “If the knives are going to come out, now is when it will happen” National Journal Group, 04-15-2006

  32. Think It Can’t Happen Here? • So did they: • Oldsmobile • One of the original car companies (1874) • After 107 years, 35.2 million cars, • Ceased production in 2004 • Winchester • Founded in 1860 • “The Gun that Won the West.” • No longer made in America after March, 2006. • RCA Victor • World’s largest manufacturer of phonographs (Victrola) • Introduced the 33 1/3 RPM • Died as a manufacturer, circa 1970

  33. Importance of the Problem:the Cancer Burden Iceland 1,000 /500 Sweden 43,000 /22,000 Norway 21,000 /11,000 Japan 521,000 /311,000 Estonia 5,000 /3,000 Canada 138,000 /66,000 Ireland 13,000 /8,000 Germany 408,000 /218,000 United States of America 1.4M /566,000 China 2.2M /1.6M United Kingdom 277,000 /156,000 Austria 37,000 /19,000 Korea 109,000 /62,000 Switzerland 35,000 /17,000 France 269,000 /149,000 7.6 millionpeople died of cancer in 2005 Republic of Singapore 10,000 /6,000 Australia 86,000 /37,000 Cancer Incidence / Mortality per year Source: Derived from International Agency for Research on Cancer, GLOBOCAN 2002 database

  34. Bottom-line • With: • Setup for each clinical trial phase taking • 2.1 years for a cooperative group, then • ~5 ½ months for a comprehensive cancer center • And a typical drug requires three phases • Then: • ~7.8 years are spent in setup paperwork • Therefore: • For Pharmaceutical Firms: • A nearly 8 years of sales are lost, along with those profits • For physicians & patients: • ~11 million new cancer patients in the US alone will not have the best treatment possible • ~4.4 million cancer deaths will not be prevented or delayed ALL BECAUSE OF PAPERWORK

  35. Thank you

  36. Does It Only Work For Manufacturing? • IBM Credit went from 7-days to 4-hours without an increase in headcount • Ford Accounts Payable had 500 people to do the same work that Mazda did with 5 • (Hammer & Champy (1993) Reengineering the Corporation) • Southwest Airlines • 10 minute turn-around time • “Ticketless” travel • No Assigned seating • Can we use the same techniques in Clinical Trials?

  37. Composition of Development Time • Typical Reported Phases • Clinical Phase • FDA Approval Phase • But can a study start once a LOI is submitted? • Or must you wait? If you wait, what are you waiting on? • Setup processes, all of which take time • But setup is not typically measured

  38. Bottleneck in the Bottleneck % of total time

  39. And the problem is getting worse • In the 1990s, the FDA approved 38 new agents for treatment of cancer and cancer-related indications, more than the preceding 40 years • The more than 100 claims approved for treatment indications during the 1990s far exceeded the total of those granted in the proceeding 40 years • (Rothenberg ML, Carbone DP, Johnson DH, Improving the evaluations of new cancer treatments: challenges and opportunities. Nature Rev Cancer 2003;3:303-9) • In one new area: nanotechnology • Understanding of cancer at the molecular level is progressing exponentially • Nano-based devices and drugs for cancer and all diseases are increasing • 68% increase in the clinical pipeline from 2005 • 130 nanotech-based drugs and delivery systems • 125 devices or diagnostic tests • (2006 Nanomedicine, Device & Diagnostic Report, National Health Information, LLC)

  40. And remember the automobile industry (Part 2) • September 15, 2006 • Ford • called for 44,000 job cuts • (The 3rd turn around in 5 years) • Conceded 2nd place in the US to Toyota • Does not expect to make a profit in NA until 2009 • Chrysler Group • Would report a loss for this summer of $1.5 billion, more than double that anticipated • September 20, 2006 • DamlierChrysler cuts 14% of workforce

  41. The Traditional USA Way • Very large, tightly integrated, monolithic plants • Extremely efficient when they operate • Terribly expensive to start, stop or change

  42. And remember the automobile industry (Part 1) • “In the mid-1970s, anybody found driving a Japanese car in Michigan was in danger of ending up with a tire slashed or a door keyed. Today, mention one of the Big Three U.S. auto-makers -- GM, Ford or DaimlerChrysler -- at a blue-collar Midwestern honky-tonk and you'll hear groans. Everybody in the Midwest these days is begging Honda to come into their hometown. It is no longer viewed as a "Japanese" company, but a "pro-American-worker" corporation flush with jobs, jobs, jobs.” Douglas Brinkley, D (2006, July 18) “Hoosier Honda”, WSJ, A14 • SHANGHAI -- Nanjing Automobile (Group) Corp., a Chinese state-owned car maker, said it is joining with two U.S. investment funds to build MG cars at a new plant in Oklahoma. • Fairclough, F (2006 July 12), WSJ, D5

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